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CompletedNCT00792207StepUpUpdated Dec 4, 2009

The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults

An interventional study of Virtual Coach software and Activity monitor and website in Overweight, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-04.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to an exercise regime.

This study is designed to examine the effect of a computer program called a "Virtual Coach" and find out if it helps people become more active. This program acts as a kind of a personal trainer and will give you feedback. All participants in the study will receive an activity monitor to wear during the study and a website to use to track activity. Half of the participants will also receive the virtual coach software. This software will have to be downloaded onto your computer, and we will ask that you check in with the coach using the software three times a week for 12 weeks. The group you will be placed in will be selected by chance.

02

Conditions studied

  • Overweight

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 70 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults age 20-55 inclusive
  • BMI between 25 and 35 inclusive (overweight and Class 1 obese subjects)
  • PC Computer with an available USB port, speakers and high-speed internet access in a secure setting (home or private office)
  • Fluency in English (spoken and written)
  • Have a Primary Care Physician
  • Answer "No" to all 7 questions on PAR-Q OR have letter from PCP clearing them to take part in study

Exclusion criteria

Exclusion Criteria:

  • Disability, medical or surgical condition preventing or precluding moderate physical activity.
  • Cognitive impairment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention Group: The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data recorded by an activity monitor.

    Other: Virtual Coach software

  • Active comparator
    Control

    The control group will use an activity monitor and will have access to a website to monitor activity, but will not receive the Virtual Coach program.

    Other: Activity monitor and website

Interventions

  • OtherVirtual Coach software

    The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data.

  • OtherActivity monitor and website

    The control group will use an activity monitor and a website to track activity levels.

06

What researchers measure

Primary outcomes

  1. The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in subject weight. Subjects will be weighed at their first study visit and their final visit.

    Time frame: 12 weeks

  2. Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit

    Time frame: 12 weeks

  3. Subject rating on the working alliance inventory score

    Time frame: 12 weeks, assessed at the end of the study

  4. Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).

    Time frame: 12 weeks

07

Study locations

1 site
  • Partners Health Care Center for Connected Health
    Boston, Massachusetts 02114, United States
08

References and documents

Publications

  • Watson A, Bickmore T, Cange A, Kulshreshtha A, Kvedar J. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial. J Med Internet Res. 2012 Jan 26;14(1):e1. doi: 10.2196/jmir.1629. PubMed 22281837 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00792207
Lead sponsor
Massachusetts General Hospital
Collaborators
Northeastern University, FitSense/FitLinxx
First posted
Nov 17, 2008
Start date
Jun 2008
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Dec 4, 2009

Study contacts

Alice Watson, MD,MPH
principal investigator · Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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